Estrogen Receptors and HER2 Levels' Expression in Luminal Metastatic Breast Cancer

Recruiting

• Conditions: Advanced Breast Carcinoma

• Registration Number: NCT06243432
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

CYCLHER is a retrospective observational multicentric italian study aimed to evaluate the correlation between hormone receptors (HR) and HER2 immunohistochemistry (IHC) levels and treatment'response in patients affected by advanced breast cancer treated with first line CDK4/6 inhibitor plus endocrine therapy.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-01
• Status Verified: 2023-10
• Study First Submitted: 2024-01-24
• Study First Submitted QC: 2024-02-02
• Study First Posted: 2024-02-06
• Last Update Submitted: 2024-04-23
• Last Update Posted: 2024-04-24
• Primary Completion: 2024-12-31
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• Age ≥ 18 yo
• Histological diagnosis of HR+/HER2- advanced breast cancer
• Immunohistochemical HER2 negative evaluation (0, 1+ or 2+ FISH-)
• Immunohistochemical expression levels of estrogen and progesterone receptors
• First line CDK4/6 inhibitor plus endocrine therapy stared up to 12/31/2020
• Signing of informed consent approved by local Ethic Committee

Exclusion Criteria

• Absence of clinical and pathological data that would compromise the definition of the study endpoints
• HER2 positive (ICH 2+ and FISH positive or HER2 3 +) or triple negative disease
• Previous chemotherapy for treatment of metastatic disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression free survival (PFS)	Through study completion, an average of 1 year".	PFS of HR+/HER2- breast cancer patients who received endocrine treatment plus CDK4/6 inhibitor as first line treatment for metastatic disease, categorized according to estrogen and progesterone receptor levels and HER2 expression status (HER2 0,1+ or 2+ FISH negative).

Secondary Outcome Measures

Name	Time	Method
Objective response rate (ORR)	Through study completion, an average of 1 year".	ORR according to estrogen and progesterone receptor levels and HER2 expression status (HER2 0,1+ or 2+ FISH negative).
Incidence of Adverse Events (AEs)	Through study completion, an average of 1 year".	AEs related to the treatment and evaluated according to CTCAE v5.0
Overall survival (OS)	Through study completion, an average of 1 year".	OS according to estrogen and progesterone receptor levels and HER2 expression status (HER2 0,1+ or 2+ FISH negative).

Trial Locations

Locations (1)

Fondazione Policlinico A. Gemelli - IRCCS; 🇮🇹 Rome, Italy